Implementing Injury Prevention Training in Youth Handball (I-PROTECT) Using the RE-AIM Evaluation Framework

NCT ID: NCT05696119

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-10-18

Brief Summary

The aim of this two-armed cluster-randomized controlled trial is to investigate the implementation of the I-PROTECT using the RE-AIM evaluation framework that addresses five dimensions of effectiveness and implementation of interventions: reach, effectiveness, adoption, implementation, and maintenance.

Detailed Description

The 'Implementing injury Prevention training ROutines in TEams and Clubs in youth Team handball (I-PROTECT)' project was initiated through dialogue between end-users and researchers with the goal of making injury prevention training an integral part of regular practice in youth handball through a series of studies. Numerous implementation barriers and facilitators were identified in previous studies within the I-PROTECT project. These determinants were addressed when designing the intervention.

The current study was planned with the Swedish Handball Federation, an organization with overall responsibility for handball in Sweden, to investigate whether I-PROTECT will work under real-world conditions and become part of regular handball practice. The specific aim is to investigate the implementation of I-PROTECT using the RE-AIM evaluation framework that addresses five dimensions of effectiveness and implementation of interventions: reach, effectiveness, adoption, implementation, and maintenance. Reach (R) is the absolute number, proportion and representativeness of individuals who are willing to participate in a given intervention. Effectiveness (E) is the impact of the intervention on outcomes. Adoption (A) is the absolute number, proportion and representativeness of settings and intervention agents who are willing to use the intervention. Implementation (I) refers to the intervention agents' fidelity to the various elements of the intervention's protocol. Maintenance (M) is the extent to which the intervention is sustained over time.

The design will be a pragmatic two-armed cluster-randomized controlled trial (cluster-RCT) conforming to the Consolidated Standards of Reporting Trials (CONSORT) statement extension to cluster-randomized trials. Eighteen randomly selected clubs in Sweden offering handball for both female and male youth players, will be randomized to intervention (I-PROTECT) or control (currently available injury prevention training). Implementation outcomes will be investigated using RE-AIM evaluation framework, collected using a study-specific questionnaire at the end of the season (approx. 9 months after study start).

Conditions

Athletic Injuries; Health Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

I-PROTECT

I-PROTECT includes physical and psychological injury prevention information and training (i.e., the intervention) and tailored support to implement it specifically developed for Swedish community youth handball.

Group Type: EXPERIMENTAL

I-PROTECT

Intervention Type: BEHAVIORAL

I-PROTECT is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes end-user-targeted information and injury prevention physical and psychological training, specifically tailored for youth handball. The intervention is delivered through a mobile application (I-PROTECT GO) specifically developed for the I-PROTECT project, including coach, player, club administrator, and caregiver modules. Tailored support to implement I-PROTECT is specifically developed for Swedish community youth handball.

Control group

Coaches of youth teams in the control group clubs will be offered currently available injury prevention training (i.e., "Redo för Handboll", English: "Ready for Handball"), accessible online through the Swedish Handball Federation's coach education material.

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: BEHAVIORAL

Coaches of youth teams in the control group clubs will be offered currently available injury prevention training (i.e., "Redo för Handboll", English: "Ready for Handball"), accessible online through the Swedish Handball Federation's coach education material.

Interventions

I-PROTECT

I-PROTECT is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes end-user-targeted information and injury prevention physical and psychological training, specifically tailored for youth handball. The intervention is delivered through a mobile application (I-PROTECT GO) specifically developed for the I-PROTECT project, including coach, player, club administrator, and caregiver modules. Tailored support to implement I-PROTECT is specifically developed for Swedish community youth handball.

Intervention Type: BEHAVIORAL

Control

Coaches of youth teams in the control group clubs will be offered currently available injury prevention training (i.e., "Redo för Handboll", English: "Ready for Handball"), accessible online through the Swedish Handball Federation's coach education material.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Clubs: Clubs in Sweden offering handball for both female and male youth players
• Teams: Training ≥2 times per week
• Youth players: Playing in boys' or girls' teams aged 12-16 years season 2023/2024
• Coaches: leading ≥1 training session/week
• Parents/guardians: directly associated with the eligible players
• Club administrators: engaged in the issues of sports injury, coach education or policy development for youth players

Exclusion Criteria

• Clubs with previous involvement in developing and/or testing I-PROTECT
• Clubs that offer handball exclusively for either female or male players
• Teams with players 17 years or older

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lund University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eva Ageberg, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

Eva Ageberg

Lund, , Sweden

Countries

Sweden

References

Ageberg E, Donaldson A, Strom A, Lucander K, Moesch K, Bunke S, Linnell J, Wedberg R, Ekberg P, Nilsen P. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: study protocol for a cluster randomised trial. BMJ Public Health. 2024 Jul 30;2(1):e000991. doi: 10.1136/bmjph-2024-000991. eCollection 2024 Jun.

Reference Type: DERIVED

PMID: 40018138 (View on PubMed)

Related Links

https://bmjpublichealth.bmj.com/content/2/1/e000991

Ageberg et al. Implementing injury prevention training in youth handball (I-PROTECT) in Sweden: Study protocol for a cluster-randomized trial

Other Identifiers

2014/713

Identifier Type: OTHER

Identifier Source: secondary_id

2022-06148-02

Identifier Type: -

Identifier Source: org_study_id